Thermographic apparatus for physical examination of patients

ABSTRACT

A passive thermographic analytical apparatus for determining the presence of cancer includes a left and right breast scanner array, each of which includes a matrix of infra-red energy sensors and reflectors mounted in a close spaced array for producing a pattern of temperature measurements. The arrays are mounted within an adjustable support to permit spatial positioning and alignment of the arrays. Each sensor produces an analog voltage proportional to the body temperature. The sensor output voltages are sequentially read and converted into appropriate digital form for storage in a RAM memory of a microprocessor, which includes a pattern recognition program to directly create an automated diagnosis of the radiation pattern from which the normality or abnormality of the breasts can be diagnosed. The various parameters are reduced to a multiple digit number which is displayed. The number is encoded to a particular condition.

BACKGROUND OF THE INVENTION

This invention relates to the thermographic apparatus for physicalexamination of a patient by directly measuring and analyzing the thermalradiation patterns of a patient's body.

Thermographic apparatus has been suggested for a number of years foranalyzing the biological condition of human patients and the like. Suchapparatus has recently more particularly been applied to the earlydetection of cancer and particularly breast cancer in female patients.Although there are variations in thermal radiation patterns of patients,recent developments and application of computers have allowedstatistical analysis which produces accurate separation between healthyand possibly cancerous patients. One satisfactory computer-based systemis more fully disclosed in a paper presented in the May 1975 issue ofRADIOLOGY, Vol. 115, No. 2, at pages 341-347, in an article entitled"Computer Diagnosis of Breast Thermograms" by Marvin C. Ziskin, M.D., etal. A thermographic technique is discussed employing the photographingof the breast area and then scanning the photograph to develop adigitized image frame. A conventional close circuit television camera isused to produce a point by point reading of the thermal conditions, withdigitizing of each point. Generally each scan line includes 192 pointsand two hundred and fifty-six scan lines are used to create adimensional array in excess of four thousand points. These numbers arestored and subsequently processed by a general purpose computer. Thedecision algorithm employs a standard statistical technique ofdiscrimination analysis in which a statistical standard is determinedand various comparisons and thresholds are checked from which adetermination of normality and abnormality is made. Although suchdiagnostic apparatus has been developed to the point where practicalresults are obtained, an apparatus such as disclosed is relativelycomplex and costly, which would significantly limit the application andusage of such a computerized thermographic system. Generally, onlyrelatively large hospitals would have a sufficient usage factor tojustify the cost. There therefore remains a need for a low costcomputer-based thermographic screening apparatus.

SUMMARY OF THE PRESENT INVENTION

The present invention is particularly directed to a passivethermographic analytical apparatus which is relatively inexpensive andprovides a direct readout of the results of the analysis of thethermographic radiation pattern of the human body, Generally, inaccordance with the present invention a multiplicity of energy sensorssuch infra-red radiation are mounted in a close spaced array forproducing a plurality of measurements of the aligned areas of the body.The sensor array is mounted within an adjustable support to permitspatial positioning of the array in accordance with the individualpatient. The multiplicity of the sensors are simultaneously orsequentially read to develop related analog signals which are convertedinto appropriate digital form and stored in a memory means forprocessing. Although any suitable hardwired system could be employed, amicroprocessor is preferably employed to process the multiplicity ofsignals in accordance with particular pattern recognition programs todirectly provide an automated diagnosis of the human radiation pattern.In accordance with one aspect of the present invention, the instrumentanalysis is reduced to an encoded readout, such as a numeric readoutwhich is suitably encoded to a particular condition. Thus, in operation,the patient merely steps in front of the scanning array apparatus, whichrapidly and practically instantaneously scans the aligned breasts anddevelops digital numbers which are processed by statistical patternrecognition programs such as disclosed in the previously referencedarticle.

In a preferred and particularly novel arrangement a pair of separatescanning arrays are provided each consisting of a matrix of thermalsensitive sensing elements such as thermopile devices which produce anoutput voltage proportional to the temperature of the thermopilejunction, and associated optical devices for collecting of the infra-redradiation in the aligned area and concentrating such energy upon thesensor sensing elements. In addition, one or more sensor elements arelocated between the two arrays for developing a reference temperatureagainst which to compare the output numbers of the array. The two arraysare mounted for separate vertical positioning and for relativehorizontal positioning for alignment with different patients.

Thermopile devices or the like are readily provided which have a veryrapid response to the energy input, and the output numbers can besimultaneously or sequentially stored in a simple rapid manner forsubsequent analysis in a resident hardwired or programmed instrumentsuch as a micro-processor.

Thus, the present invention provides a simple, reliable and relativelyinexpensive thermographic system or instrument for directly producing anencoded output indicative of the conditions monitored. The inventionthus provides a low cost, screening instrument for breast cancer, andthe like.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings furnished herewith illustrate a preferred embodiment of thepresent invention in which the above advantages and features are clearlydisclosed as well as other which will be readily understood by thoseskilled in the art.

In the drawings:

FIG. 1 is a front elevation view of the scanning apparatus andinter-related data processing control unit constructed in accordancewith the present invention;

FIG. 2 is an enlarged vertical section through an array unit shown inFIG. 1;

FIG. 3 is a rear view of the apparatus shown in FIG. 1 and illustratinga suitable positioning apparatus;

FIG. 4 is a fragmentary enlarged view of a portion of FIG. 1 for clearlyillustrating details of the thermal sensor assembly;

FIG. 5 is a fragmentary vertical section taken generally on line 5--5 ofFIG. 4; and

FIGS. 6 and 7 are a schematic electronic circuit used to multiplex,amplify and process the output of the sensing arrays illustrated onFIGS. 1-5.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

Referring to the drawings and particularly to FIGS. 1 through 3, abreast cancer thermographic diagnostic apparatus is shown including abreast scanning unit 1 adapted to be mounted in relatively fixedrelationship with respect to a patient 2. The apparatus includes firstand second similar thermal measurement array units 3 and 4 which areadjustably mounted for selective and precise alignment with the breastof the patient 2. Each array unit 3 and 4 consists of a selected matrixor arrangement of individual similar temperature sensitive assemblies 5such as assemblies which are responsive to the infrared radiation fromthe body of the patient and particularly responsive to the alignedportion of the breasts as more fully developed hereinafter. A referencetemperature assembly 5a is located between the array units 3 and 4. Theoutput of the scanning unit 1 is coupled by a suitable power and signalcable 6 to an analyzing and display module 7. In a preferred embodiment,the module 7 is a microprocessor-based system such as disclosed morefully in FIGS. 6 and 7 and hereinafter discussed. Generally, the module7 includes means to convert the output of the individual sensingassembly 5 into an appropriate digital number which is subsequentlyprocessed by the module 7 through a series of pattern recognitionprograms in order to establish a positive or negative cancer diagnosis.The output of the analysis is presented in a digital manner on a numericreadout 8 on the front of the module 7. A significant factor in theanalysis is the patient's age. A numeric input means shown as a pair ofthumbwheels 9 is provided for the age entry. Other conventional controlssuch as a power switch buttom 10 and on-off lamp 11 and the like mayalso be provided. A start-reset key 12 is provided for initiating adiagnostic cycle.

In operation of the apparatus, the patient 2 is located in front of thescanner apparatus 1. The scanning array units 3 and 4 are properlylocated with respect to the particular patient. The start key 12 isactuated and the thermal radiation pattern of the right and left breastsas well as the temperature of the sternal region 13 between the twobreasts is read. The output of the array units 3 and 4 is acorresponding series of voltage signals which are individually anddirectly related to the average temperature of the breast portionsaligned with the temperature sensitive assemblies 5. Thetemperature-related voltages are converted to a digital form and thenprocessed by the microprocessor through the pattern recognition programto produce the positive or negative breast cancer diagnosis. Theprocessor is programmed to directly indicate by a numeric reading on thedisplay 8 of the computer module 7 an indication of normality orabnormality. This reading may also indicate the degree of certainty ofthe diagnosis.

More particularly, in the illustrated embodiment of the presentinvention, the scanner apparatus 1 includes a rectangular frame 14within which units 3 and 4 are mounted. Each of the array units 3 and 4includes an 8×8 matrix of temperature sensitive assemblies 5. Theassemblies 5 are arranged in well known columns and rows to define asquare matrix, although any other matrix arrangement can of course beemployed. Each unit 3 and 4 is similarly constructed, and includes asupport board 15 which is mounted for vertical and horizontal movementas most clearly illustrated in FIGS. 1 and 3. Referring to array unit 4,a vertically oriented positioning bolt or shaft 16 is rotatablysupported within the top and bottom legs of the frame 14. A supportplate 17 includes a threaded nut portion 18 threaded onto the threadedshaft 16. A hand wheel 19 is secured on the upper end of bolt 16 forvertical positoning of plate 17. The board 15 is affixed to a slidingblock 20 as by screws 21. The block 20 is located within a recessopening 22 in the support plate 17. The block 20 includes a threadedopening, shown as a nut 23, for receiving a laterally positionedthreaded shaft 24 which is rotatably journaled at the opposite ends inthe plate 17. Rotation of the shaft 24 therefore provides lateralpositioning of the block 20 and attached array unit 4 within therectangular opening 22. A handwheel 25 permits convenient horizontalpositioning of the unit 4. The array unit 3 is similarly supported forvertical and horizontal positioning, and corresponding elements areidentified by corresponding primed numbers.

In addition, a reference cell unit 26, which may consist of a singleassembly 5 is located between array units 3 and 4. The location of unit26 is not critical and the unit 26 may conveniently be attached toeither of the units 3 and 4 for relative movement therewith or the frame14 and may provide for adjustment in the positioning relative to units 3and/or 4. The unit 26 is shown attached to unit 4 for purposes ofillustration.

Any other adjustable positioning can be provided for the individualarray units, which may of course include similar or other means for theindividual vertical and horizontal movements of the left and rightarrays.

As previously noted, each of the illustrated array units 3 and 4 issimilarly constructed and each similarly supports individual sensingassemblies 5, a preferred embodiment of which is more clearly shown inFIGS. 2, 4 and 5; and one unit 5 as shown in FIGS. 4 and 5 isparticularly described. The assembly 5 includes a thermal sensitiveelement or device 27 which is a relatively small, compact element havinga diameter smaller than the area to be scanned by the measurementdevice. A particularly satisfactory device is a thermopile measurementdevice of type S15 manufactured and sold by Sensors, Inc. The S15 deviceis a multiple-junction thin-film thermopile construction having anexposed active area 28 on one end. The device 27 generally includes acylindrical housing 29 of approximately one-half inch or 10 millimeterdiameter and having a pair of positive and negative connecting leads 30and 31 and a case support wire 32 secured to the outer or base of thehousing. The active area 28 is exposed through an opening in theopposite end of the housing 29 and is on the order of 1.5 millimeterssquare. The active area of the sensor in such a unit is generallyconstructed as more fully disclosed in U.S. Pat. No. 3,715,288.

As most clearly shown in FIG. 5, the sensor is mounted with the activearea 28 facing the board 15, by bending of the three leads 30-32 backabout the exterior of the casing 29. The leads 30-32 are suitablysecured to pin elements 33 embedded in the array board 15. The positiveand negative leads 30 and 31 are secured to terminal pins 33 whichextend through the board 15 with the opposite ends interconnected tocircuit leads 34 for interconnecting of the thermopile 28 into theappropriate circuit as hereinafter described.

The active area 28 is aligned with the center of a small convex mirror35 which is secured or firmly affixed to the board 15 by a suitableadhesive 36 or the like. The mirror 35 is substantially larger than thesensing element 27 and collects the infrared radiation from the alignedbreast portion and concentrates such energy upon the active area 28 ofthe element 27. The output voltage of the element 27 is a voltageproportional to the average termperature of the aligned portion of thebreast.

The mirror may be formed of suitable acrylic material having a highlypolished mirror surface to collect and reflect the energy onto theactive area 28. Such mirrored devices can be readily provided by thoseskilled in the art and no further description thereof is given.

The output of the several sensing assemblies 5 and 5a are individuallyinterconnected to the module 7 through any suitable terminal means 37and 38 shown provided on the lower end of circuit boards 15. Thus, inthe illustrated embodiment of the invention, a suitable multiple leadcable strip 39 interconnects the terminal means 38 to a couplinginterface circuit means 40 at the lower end of the circuit board 15 ofthe unit 4, with the terminal means 37 of unit 4 interconnecting to themeans 40. The output is connected by cable 6, which is also a multiplelead connecting strip, to the computer module 7.

The computer module 7 may be of any suitable construction and apreferred structure is shown in FIG. 6, for purposes of clearlydescribing the invention.

Referring particularly to FIG. 6, the individual sensors are showndivided into groups of 16, each group being coupled to an individual16×1 multiplexing circuit board 41. The sensing assemblies 5 thusproduce eight different circuits 41, with the eight output lines 42connected as the input to a 16×1 multiplexer 43. Each multiplexer 41 issimilarly constructed with suitable address lines 44 for addressing aparticular sensing assembly 5 and transmitting of the voltage signalthrough the multiplexer 41 to multiplexer 43, which similarly has inputaddress lines 45 for coupling the lines 42 in sequence to an output line46. The multiplexer 43 also includes inputs connected to the referencesensing unit 25, which reading is coupled to the output line 46 in eachsequence. Thus, each of the voltages generated as a result of theinfrared radiation is sequentially transmitted to the output line 46.

Each of the signals is suitably shaped and amplified in a suitableamplifier circuit or unit 47, which is readily and commerciallyavailable. The illustrated circuit includes a pair of cascaded operationamplifiers, the first of which includes an offset network 47a. Theamplified voltage signal is applied to an analog to digital converter 48which converts each analog signal into a suitable multiple bit binarynumber or word suitable for processing in a suitable microprocessor. Thesuccessive approximation type analog to digital converter 48 is of anysuitable construction and is shown as a well known chip having feedbackcircuit 48a of a conventional construction. Suitable starting and clockinput controls from the computer enable the analog and digital converter48 and initiate the reading and conversion cycle. Thus, each voltagesignal is converted into an eight bit binary word which is coupledthrough an interfacing circuit chip of unit 49 to a microprocessorsystem 50 FIG. 7.

The illustrated microprocessor 50 includes a central processing unit(CPU) 51 shown as the well-known MSC6502 chip manufactured and sold byMOS Technology, Inc. The microprocessor system 50 includes a read onlymemory 52 in which the basic control as well as the thermal diagnosticprograms are stored and a random access memory 53 for storing andprocessing the voltage signals in accordance with the programs. Theillustrated processor system 50 thus includes a set of processor andsystem control lines for initiating and sequencing the operation of thesystem and for synchronizing of the several functions and processingsequences. A bidirectional data bus 54 is coupled through data busdrivers 55 to the data inputs for transmitting and receiving of data toand from memories 52,53, and I/O components such as the A/D converterinterface unit 49, the age entry dial units 9 and the readout or displayunit 8. Data bus 54 is an eight line bus for transmitting of eight bitdata words. In addition, the processor unit 51 includes a set of addresslines, which in the illustrated embodiment includes 16 individualaddress lines. The address lines are interconnected through suitable busdrivers 56 to a sixteen line address bus 57 coupled to the memories andthe I/O components for appropriately addressing of the several devicesduring the processing cycle.

The processor unit 51 also includes control lines 58 coupled throughsuitable logic circuits for sequencing of the several routines andparticularly for reading of the sensors, processing said signals,storing of the processed signals and then calculating of variousparameters from which the numeric display value is calculated anddisplayed.

The start or reset key 12 controls 9 switch 60 connected in a pulsecircuit 61 for signaling of the control lines 58 including a reset line6/a to reset the processor 51 for starting of a processing cycle fromthe first instruction in memory 52.

The read only memory (ROM) 52 is shown as an eraseable read only memoryin which the program is stored for controlling of the system. The memory52 includes a plurality of 2708 chips 62 which are connected to thecommon data bus 54 through suitable buffer drivers 63, shown as 8T96chips. The several chips 2708 are also coupled to the address lines 0through 9 of the address bus 57 through suitable buffer driver 64 shownas 8T95 buffer chips. A chip selection decoder 65, shown as an 74LS138chip, includes eight output select lines 66, connected one each to the 8ROM 2708 chips. The decoder 65 includes 3 address inputs connected toaddress lines 10, 11 and 12 of the address bus 57 and a further input"coded" to the address lines 13, 14 and 15 through a NAND gate 67 suchas a 74LS10 chip. The several inputs are decoded by the decoder 65 toselectively enable one of the 2708 chips of ROM 52. The output of theNAND gate 67 is also connected by a signal line 68 to enable the bufferdrivers 63 and 64 interconnected between the ROM inputs and the ROMaddress and data buses 54 and 57 to enable the corresponding driverswhenever the ROM memory has been selected for communication with theprocessor.

The RAM memory 53 is shown including eight AM9140E chips 69 with addresslines 70 coupled to the address bus 57 and particularly lines "0-11". Aselection logic circuit 71 includes a NAND gate 72 connected to threeaddress lines and an OR gate 73 connected to the output of the NAND gate72 and address line 13. The chips 69 include the usual control inputsand input and output lines coupled to the data bus 54 by a pair ofbidirectional buffer drivers 74, also shown as 8T28 chips.

Referring to FIG. 6, the data interfacing unit 49 is shown as a knownMCS6520 chip which includes a plurality of control lines 75 coupled tothe corresponding lines and sequence control of the microprocessor 51 assubsequently described. The interfacing unit 49 includes a plurality ofinterfacing lines, including a group or set of 8 data input lines 76 andcontrol lines 77 connected to the A/D converter 48 for activating thelatter and reading the converted binary numbers. The interfacing unit 49include group or set of multiplex address lines 78 and 79 defining themultiplex selection address lines and connected to the input lines 44and 45 of the multiplexers 41 and 43. A driver 80, shown as an 8T95chip, is shown coupling multiplex address lines 78 to the multiplexer41. Finally interfacing unit 49 includes bidirectional input linescoupled to receive and transmit data and coupled to receive and transmitdata coupled to the microprocessor system data bus 54 by suitable bufferdrivers 81. The digitized sensor voltage signals are thus read by theprocessor unit 51 and stored in the RAM memory unit 53.

The processor unit 51 selectively enables the several components byaddressing a selection decoder 81 shown as a 7442 chip, having threeinput lines 82 connected to the address lines 13, 14 and 15 of theaddress bus 57. Decoder 82 has four output lines 83. The first outputline is connected to enable the interfacing unit 49, and conjointly withthe read/write control line of lines 75 is connected by a logic circuit84 to enable the drivers 81.

The patient's age is introduced using a pair of conventional series 300digiswitches 85 settable by thumb-wheels 9, having 10 dial positions andproviding an output numbers in BCD. The pair of switches providedinclude a most significant digit and a least significant digit. Thebinary output signals of these switches are connected by a pair ofbuffers 86 to the data bus 54. The buffers 86 are shown as 8T09 chipshaving the enabling inputs connected to the second output of lines 83 ofthe decoder 82.

The display unit 8 includes four 7 segment LED units 87. Latch units 88connect segment input lines to the data bus 54. The latch units 88 haveselection inputs connected to the third and fourth output lines of theaddress decoder 82.

In use, the patient is located in front of the arrays units 3 and 4,which are then vertically and horizontally properly aligned with thepatient. The system operation is initiated by activation of the start orreset switch 60. The processor 51 resets to the initial or startingprogram address of the programmed ROM memory 52 which provides the usualhousekeeping routine to initialize all of the necessary elements. Theprogram then proceeds to sequentially read the total of the 129 sensorassemblies 5 and 51, 64 sensors for each of the breast scanning unitsand the reference sensor assembly 5a for determining the referencetemperature in the sternal area. Each sensor voltage, which is directlyproportional to the average temperature of the breast portion alignedwith the mirror 35, is sequentially read through the multiplexing systemand digitized by the A/D converter 48. The numbers are converted by theprocessor 51 into a BCD number which is stored in the RAM memory 53. Thenumbers are preferably stored in two floating point arrays, identifiedas the left and right arrays. In accordance with known conventions, thefloating point number may consist of the five binary bytes in which thefirst byte identifies the most significant bit while the second, thirdand fourth bytes include the mantissa digits of the BCD numbers and thefifth byte includes the exponent. Each point number and referencetemperature number is adjusted by the processor 51 such that the rangeof input values lies between 0 and 511, and then the 511th complement ofall numbers is taken. A value of "0" defines a point that is hot while avalue of "511" defines a point that is cold. Each temperature point ineach array is considered cold if its temperature number is greater thanthe reference temperature and hot if its temperature number is smallerthan the reference temperature number. The total temperature pattern israpidly determined and stored as a pattern of digital numbers in thememory 53 in relatively short period of time and particularly with arelatively inexpensive and reliable scanning apparatus.

After storage of all of the data, the microprocessor executes a seriesof pattern recognition programs to develop an automatic diagnosis, andfinally to display in numeric form the result of such diagnosis inencoded numeric form upon the display.

Generally the invention may employ the several individual parametersmore fully developed in the previously referenced Ziskin Article, atable of which is reproduced below:

                  TABLE I                                                         ______________________________________                                        ELEMENTAL FEATURES                                                                                    Parameter                                             Name                    Number                                                ______________________________________                                        Hottest gridel on left  P8                                                    Hottest gridel on right P9                                                    Horizontal "shift" between left                                                and right hottest gridel                                                                             P10                                                   Vertical "shift" between left                                                  and right hottest gridel                                                                             P11                                                   Hottest region on left  P12                                                   Hottest region on right P13                                                   Areolar temp. on left   P20                                                   Areolar temp. on right  P21                                                   Reference temperature   P5                                                    Average temperature of left breast                                                                    P26                                                   Average temperature of right breast                                                                   P27                                                   Average temperature of all hot                                                 regions on left        P18                                                   Average temperature of all hot                                                 regions on right       P19                                                   Total hot area on left  P16                                                   Total hot area on right P17                                                   Highest P.sup.2 /A value on either                                             side                   P24                                                   Lowest P.sup.2 /A value on either                                              side                   P25                                                   Number of hot regions on left                                                                         P22                                                   Number of hot regions on right                                                                        P23                                                   ______________________________________                                    

The above parameters are elemental parameters based on the previouslyidentified articles from which various analyses and comparisons aredeveloped, as more fully developed hereinafter, to produce a suitableindication of the probable presence of breast cancer.

The elemental features or parameters of the above table are calculatedby suitable processing algorithms for each of these parameters, such asthe following which parameters are similar to those described by Ziskinand a suitable program for processing of each is shown in Appendix "A"of record. The program employs the KIM MATH package provided with the6502 microprocessor.

Hottest Gridel on Left (P8)

This parameter indicates the temperature of the hottest single gridel onthe left side. The processor is programmed to search the left arraymemory for the minimum value. The address of the left side array is setin the appropriate registers using SADLST and SADLSY routines. The firstnumber of the array is moved into RY register by using the KIMATHroutine PLOADY and the second number is loaded into RX register by usingthe KIMATH routine PLOADX. The ADD routine is called to compare the twomembers and the smallest absolute value on return is place in RYregister. The rest of the numbers in the array are compared with therunning minimum number. When all the 64 numbers are compared, the RYregister has the smallest number in the array, which is copied into theRZ register. The KIMATH routine PSTRES is used to store the number fromRZ register into the P8 register. This routine also converts from thecomputational format of RZ (18 bytes) into the packed format of P8 (5bytes). The algorithim for the left side is P8=Min. LST(i), i=0 to 63

Hottest Gridel on Right (P9)

This parameter is similarly found by searching the right side (RST)array.

Symmetry Parameters (P10, P11)

These two parameters measure the symmetry in the relative anatomicplacement of the hottest gridels on the two breasts. P10 is thehorizontal shift while P11 is the vertical shift between these twohottest gridels. The location in the matrix of the hottest gridel ineach side is found. LHGL(1) is the location of the hottest gridel on theleft and LHGR(1) is the location of the hottest gridel on the right.Also the following variables of interest are calculated:

CL is the column number of the hottest gridel on the left and the valuein the right most 3 bits of LHGL(1)

RL is the row number of the hottest gridel on the right and is found byshifting LHGL(1) right by 3 bits.

CR is the column number of the hottest gridel on the right and the valuein the rightmost 3 bits of LHOR(1)

RR is the row number of the hottest gridel on the right and is found byshifting LHRG(1) right by 3 bits.

These four variables for the 8×8 matrix have a range of 0 to 7 and P10and P11 are calculated therefrom by the following algorithm:

    P10=|(7-CL)+CR|

    P11=|RL-RR|

The parameter P10 has a range of 0 to 14 while parameter P11 has a rangeof 0 to 7.

Areolar Temperature on left and right sides identified as parameter P20and P21

are determined by similar algorithms, which stated for the left side is

    P20=(LST(27)+LST(28).sub.4)+LST(35)+LST(36)

The Average Temperature of the left and right are similar by calculated,as parameters (P26) and (P27)

This average temperature is that of all 64 gridels on the respectiveside. The algorithm for the left side is ##EQU1##

Hottest Region on Left and Right (P12, P13)

P12 is given by the hottest set of connected gridels or the left. It iscalculated by finding the minimum ratio (max temperatures) of the sum ofall connected gridels in a region divided by the number of hot points inthe region. After the Connection Algorithm, given below, is run for theleft side, it is given by MTEMP(5). MTEMP is copied to P12. Theparameter (P13) for the right side is then determined in a similarmanner and stored in P13.

Connection Algorithm

The connection algorithm is used to find various hot regions in therespective sides. A hot region is defined as a collection of connectedhot gridels. Two hot gridels are said to be connected if a continuousline can be enscribed between them which traverses only over hotgridels.

First of all, a dummy array is generated in the routine GDARR. The dummyarray identified as SDA(i), i=0 to 99 consists of hot and cold points.For each point in the LST or the RST arrays, the gridel temperature issubtracted from the reference temperature. If the result is negative,the point is considered cold and `00` is stored in the corresponding SDAlocation. Otherwise x`80` is stored indicating that the point is hot.There are only 64 valid points in the SDA array which correspond to theLST or the RST arrays i.e. 11-19, 20-24, 31-39, 41-49, 51-59, 61-69,71-79, 81-89. All other points from 0 to 99 are only dummy points andare considered cold.

Connection Algorithm Flowchart

The flowchart for the connection Algorithm is given in FIG. 1, (attachedas a part of the Appendix). The SDA array is searched/scanned from 0 to99 for a hot point. The perimeter of the first hot point is calculatedin the routine CALPER. If SDA(i) is the point being assigned in thefollowing array:

    ______________________________________                                        i - 11         8-10       i - 9                                               i - 1          SDA(i)     i + 1                                               i + 9          i + 10     i + 11                                              ______________________________________                                    

the perimeter P is given by: ##EQU2## where SDA i=0 if it is hot, and =1if it is cold. All other points in the SDA array are scanned andperimeters of other hot points which are immediately adjacent to thefirst point are calculated. Since the SDA array was scanned in sequence0 to 99, there may be additional neighbors to newly assigned points inthe region, hence a number of passes through the SDA array are madeuntil no more meighbors are located for that region. All points whichare assigned are masked uniquely by storing the perimeter or'ed with thenumber x `40` in order to make sure that there is no conflict withassignable points (s`80`). The higher P2/Q ratio and the lowest P2/Qratio is maintained by comparing new values for each region with theprevious maximum and minimum values (P24 and P25). When the connectionalgorithm is run for both the left and the right sides, P24 and P25 havethe maximum and the minimum P2/A ratio respectively.

Total Hot Area on Left and Right (P16, P17)

This parameter is equal to the number of hot gridels on the respectivesides. The number of hot gridels on each side is calculated by countingthe number of hot points in the SDA array. All points in the SDA arraywhich have x`80` are hot points. Besides the parameter P16 in thefloating point format, a binary count of the number of hot points isaccumulated in HGRC(i), for use in the connection algorithm. Also thesum of all hot point temperature is accumulated in STEMP(5).

Average Temperature of the hot regions of left and right sides are (P18,P19)

P18 is the average temperature of the entire hot region on the leftside. It is calculated by dividing STEMP(5) by parameter P16 and storesas parameter P18. The parameter P19 is similarly calculated and storedusing parameter P17.

Number of Hot Regions on Left and Right (P22, P23)

R(5) has the number of hot regions on left after the connectionAlgorithm is run for the left side.

After all of the elemental features set forth in the above table havebeen calculated and the results stored in memory, compound parameterscalculation are developed in a straightforward manner. In the presentembodiment of the invention, thirteen compound parameters correspondingto selected parameters set forth in the Ziskin article are employed asfollows:

    ______________________________________                                        B1 = patients age, same as P4(age)                                            B2 = ABS(P17 - P16)                                                                             Diff. in no. of hot gridels                                 B3 = ABS(P9 - P8) Diff. in no. hottest gridel Temp.                           B4 = ABS(P21 - P20)                                                                             Diff. in Average Aerolate Temp.                             B5 = ABS(P27 - P26)                                                                             Diff. in Average Temp.                                      B6 = ABS(P25 - P24)                                                                             Diff. in P.sup.2 /A ratios                                   ##STR1##         Ration of hottest gridel to Reference                       B8 = Max(P16, P17)                                                                              Largest hot areas                                            ##STR2##         Temp., normalized hot breast                                B10 = SQRT(P10).sup.2 + (P11).sup.2                                                               Symmetry shift                                            B11 = ABS(ABS(P23 - P22) - 1)                                                                     Diff. in No. of Hot                                                           Regions                                                    ##STR3##                 Diff. in Heat Emission                               ##STR4##         Diff. in Temp. Ratios                                       ______________________________________                                    

As in the article, in addition to such compound parameters the patient'sage is introduced as a parameter. As noted in the article otherparameters could be developed and employed.

Thus with all of the parameters available the combined effect of theseparameters are summated in an appropriate program of pattern recognitionto determine the positive or negative breast cancer diagnosis. Thenumerically related condition or state number (Z) is calculated basedupon the combined effect of the 13 compound parameters. The algorithm is##EQU3## wherein Ai's are the weights assigned to each parameter. Thevalues of these weights which have been employed are:

    ______________________________________                                        Al = 1.0,       A2 = .1,     A3 = .4                                          A4 = .04,       A5 = .1,     A6 = .03                                         A7 = 10,        A8 = .1,     A9 = 10                                          A10 = 2,        A11 = -2,                                                     A13 = -80                                                                     ______________________________________                                    

The above Z-value program is a direct routine program which can bereadily provided by those skilled in the art. The Z-value or number iscalculated relative to the number 500 in accordance with the previousnumber manipulation and as a result, only positive values are obtained.This value will be a number ranging from 0 to 160. To display the Avalue the exponent Z+4 is first checked to determine if the value is 2.If yes, the two most significant digits are displayed from the Z+1 andthe two least significant digits are displayed from Z+2. If the exponentZ+4 is not 2, but is 1 or 0, the Z+1 and the Z+2 bytes are shifted tothe right by either 4 or 8 bits respectively and then displayed. Theprocessor 51 is thus programmed to first determine the number to bedisplayed and then the Led display 8 is addressed for displaying of theappropriate digital number. The display is a number which is directlyrelated to the diagnostic result providing a reliable indication of thepositive and negative cancer diagnosis. The multiple digit number isemployed to indicate not only the positive or negative results but thedegree of certainty of the diagnosis since many diagnosis are not adefinite yes or no but may have various degrees of probability.

All of the components employed in the physiological diagnosticinstrument of this invention as disclosed in the above embodiment arepresently commercially available. The construction of the apparatus doesnot require any unusual or sophisticated arrangements. The illustratedembodiment of the invention thus provides a highly satisfactoryapparatus based on proven programs of analysis providing a highlyreliable screening result.

Although the illustrated embodiment of the invention employs infraredradiation emitted by the surface of the patient, other forms ofradiation could of course be employed.

Various modes of carrying out the invention are contemplated as beingwithin the scope of the following claims particularly pointing out anddistinctly claiming the subject invention.

I claim:
 1. A physiological thermographic detection apparatus comprisingfirst and second multiple sensor array means each defining a sensingarea, said arrays each including a plurality of individual thermallyresponsive units located in a selected pattern and developing individualsignals related to the thermal state of the body of an aligned patient,a thermally responsive reference unit, support means, mounting meanssecuring said array means to said support means and including adjustmentmeans for independently positioning each of said arrays relative to eachother and with respect to said reference unit, a digital memory means,reading means for recording of the individual signals in said memorymeans, means for processing of said signals in accordance with a spatialpattern recognition program within each array and in one array relativeto the other and in the first and second arrays relative to saidreference unit to produce an automatic determination of the significanceof said signals, and means for displaying of an encoded signalindicative of the diagnostic result of the pattern recognition process.2. The apparatus of claim 1 wherein each of said thermally responsiveunits are mounted in a common plane which is adapted to be located inclose spaced relationship to a human body and each of said unitsincludes a thermal sensor and an energy collection means associated witheach sensor for collecting of the energy over the aligned portion of thepatient's body and concentrating of such energy upon said thermal sensorto generate an analog signal proportional to the temperature of thealigned portion.
 3. In the apparatus of claim 1 wherein each of saidthermally responsive units includes a thermally activated sensor and anoptical reflector means located in aligned spaced relation to thesensors and mounted in spaced alignment therewith, said mounting meansfor said array means including vertical locating means for locating ofthe first and second matrix in a corresponding vertical position andhorizontal locating means for relative horizontal positioning of thefirst and second array means relative to each other and into alignmentwith selected body portions of a patient, and circuit means connected tosaid first and second array means for selected connection of saidsensors to said memory means.
 4. The detection apparatus of claim 1wherein said means for processing of said signals includes amicroprocessor input reading means connected to said responsive unitsfor separately reading of each of said analog signals and digitizingsaid signals and having address means for sequentially actuating saidreading means to read the signals of said thermally responsive units andstore said digitized signals in predetermined locations in said memorymeans in accordance with the first and second array means and thereference unit, and said microprocessor having a programmed processingmeans connected to said addressing means and to said memory means forlocating selected maximum and minimum stored signals in each of saidarrays and for calculating biologically related parameter numbers basedupon said maximum and minimum stored signals within each array and inone array relative to the others and relative to the reference unit andprocessing the summated biologically related parameter numbers andgenerating a related number as said encoded signals.
 5. The apparatus ofclaim 4 wherein each of said array means each includes a similar matrixof said thermally responsive units, each of said responsive unitsincluding a thermal sensor and an associated individual optical memberfor collection of energy and concentration of such energy upon theassociated thermal sensor for individual separate measurement of thethermal characteristic aligned with the optical member, and saidadjustment means providing for relative universal spacial movement ofthe arrays relative to each other in a common plane for locating of saidarrays with respect to spaced areas of the individual patient for anydesired location of the individual arrays.
 6. The apparatus of claim 5wherein said reference unit includes a separate sensor for alignmentwith the region between the two arrays for establishing a referencetemperature number, said reference unit being attached to one of saidarrays for simultaneously positioning therewith, and means for storingsaid reference temperature number in said memory means.
 7. The apparatusof claim 6 wherein each of said arrays includes at least 64 individualsensors and associated optical reflector members arranged in an 8×8 inchgrid, each of said sensors developing an analog signal proportional tothe thermal energy, said reading means including means for converting ofsaid analog signal into digital signals for storage in said digitalmemory, and said microprocessor being connected to said memory means andincluding address means and processing means for processing of thestored signals in accordance with said pattern recognition programs toproduce an automatic diagnostic result based on mathematicalcomputations employing the stored signals.
 8. A physiologicalthermographic detection apparatus comprising first and second multiplesensor array means, means for separately and independently positioningeach of said arrays relative to each other and relative to a patient,each array means defining a sensing area and each array means includinga plurality of individual sensor units located in a selected and fixedpattern and developing individual analog voltage signals related to theinfrared radiation of the body of an aligned patient, a multiplexingmeans connected to said sensor units and having an output means, adigital memory means, an analog-to-digital converter connected to saidoutput means, means for actuating said multiplexing means tosequentially read said analog voltage signals and means for recording ofthe individual signals in said memory means, a microprocessor means forprocessing of said stored signals to determine the location and varioustemperature characteristics of various areas in accordance with aspacial pattern recognition program of normal and abnormal temperatureswithin each array and in an array relative to the other array, means toassign different numerical significance to the determined parameters andto summate the individual determinated parameters for the various areasand thereby produce an automatic diagnostic result of the significanceof said signals, and a readout means for displaying of an encodedalphanumeric display of the diagnostic result of the pattern recognitionprocess.
 9. The apparatus of claim 8 wherein each of said thermallyresponsive units senses the radiation over the aligned portion of thepatient's body and produces an analog signal proportional to the totalradiation over such area.
 10. The apparatus of claim 9 wherein each ofsaid array means includes a rectangular matrix of said sensor units,each of said sensor units including a radiation sensor and an opticalmeans located in aligned spaced relation to the sensors and mounted inspaced alignment therewith for collecting and concentrating saidradiation on the sensor.
 11. The apparatus of claim 10 including aseparate support for each array means for locating of the first andsecond matrix in a corresponding vertical position, and means forrelative horizontal positioning of the first and second matrix relativeto each other and into alignment with selected body portions of apatient.